Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 079087
Company: IMPAX LABS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
OXYMORPHONE HYDROCHLORIDE OXYMORPHONE HYDROCHLORIDE 5MG TABLET, EXTENDED RELEASE;ORAL Prescription AB No No
OXYMORPHONE HYDROCHLORIDE OXYMORPHONE HYDROCHLORIDE 7.5MG TABLET, EXTENDED RELEASE;ORAL Prescription AB No No
OXYMORPHONE HYDROCHLORIDE OXYMORPHONE HYDROCHLORIDE 10MG TABLET, EXTENDED RELEASE;ORAL Prescription AB No No
OXYMORPHONE HYDROCHLORIDE OXYMORPHONE HYDROCHLORIDE 15MG TABLET, EXTENDED RELEASE;ORAL Prescription AB No No
OXYMORPHONE HYDROCHLORIDE OXYMORPHONE HYDROCHLORIDE 20MG TABLET, EXTENDED RELEASE;ORAL Prescription AB No No
OXYMORPHONE HYDROCHLORIDE OXYMORPHONE HYDROCHLORIDE 30MG TABLET, EXTENDED RELEASE;ORAL Prescription AB No No
OXYMORPHONE HYDROCHLORIDE OXYMORPHONE HYDROCHLORIDE 40MG TABLET, EXTENDED RELEASE;ORAL Prescription None No Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
12/21/2010 ORIG-3 Approval

Label is not available on this site.

07/22/2010 ORIG-2 Approval

Label is not available on this site.

06/14/2010 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/11/2019 SUPPL-38 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

09/20/2018 SUPPL-35 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

09/18/2018 SUPPL-32 REMS - MODIFIED - D-N-A

Label is not available on this site.

05/26/2017 SUPPL-29 REMS-Modified

Label is not available on this site.

09/28/2018 SUPPL-28 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

12/16/2016 SUPPL-27 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

09/30/2016 SUPPL-26 REMS - MODIFIED - D-N-A

Label is not available on this site.

12/16/2016 SUPPL-24 Labeling-Package Insert

Label is not available on this site.

12/15/2016 SUPPL-21 Labeling-Package Insert

Label is not available on this site.

04/20/2016 SUPPL-20 REMS-Modified

Label is not available on this site.

06/26/2015 SUPPL-18 REMS-Modified

Label is not available on this site.

08/19/2014 SUPPL-17 REMS-Assessment

Label is not available on this site.

04/16/2014 SUPPL-12 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

04/15/2013 SUPPL-6 REMS-Proposal

Label is not available on this site.

10/12/2012 SUPPL-5 REMS-Proposal

Label is not available on this site.

10/12/2012 SUPPL-4 REMS-Proposal

Label is not available on this site.

05/22/2012 SUPPL-1 Labeling-Package Insert

Label is not available on this site.

OXYMORPHONE HYDROCHLORIDE

TABLET, EXTENDED RELEASE;ORAL; 5MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
OXYMORPHONE HYDROCHLORIDE OXYMORPHONE HYDROCHLORIDE 5MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 079046 ACTAVIS ELIZABETH
OXYMORPHONE HYDROCHLORIDE OXYMORPHONE HYDROCHLORIDE 5MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 200822 HIKMA
OXYMORPHONE HYDROCHLORIDE OXYMORPHONE HYDROCHLORIDE 5MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 079087 IMPAX LABS
OXYMORPHONE HYDROCHLORIDE OXYMORPHONE HYDROCHLORIDE 5MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 202946 SPECGX LLC

TABLET, EXTENDED RELEASE;ORAL; 7.5MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
OXYMORPHONE HYDROCHLORIDE OXYMORPHONE HYDROCHLORIDE 7.5MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 079046 ACTAVIS ELIZABETH
OXYMORPHONE HYDROCHLORIDE OXYMORPHONE HYDROCHLORIDE 7.5MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 200822 HIKMA
OXYMORPHONE HYDROCHLORIDE OXYMORPHONE HYDROCHLORIDE 7.5MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 079087 IMPAX LABS
OXYMORPHONE HYDROCHLORIDE OXYMORPHONE HYDROCHLORIDE 7.5MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 202946 SPECGX LLC

TABLET, EXTENDED RELEASE;ORAL; 10MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
OXYMORPHONE HYDROCHLORIDE OXYMORPHONE HYDROCHLORIDE 10MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 079046 ACTAVIS ELIZABETH
OXYMORPHONE HYDROCHLORIDE OXYMORPHONE HYDROCHLORIDE 10MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 200822 HIKMA
OXYMORPHONE HYDROCHLORIDE OXYMORPHONE HYDROCHLORIDE 10MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 079087 IMPAX LABS
OXYMORPHONE HYDROCHLORIDE OXYMORPHONE HYDROCHLORIDE 10MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 202946 SPECGX LLC

TABLET, EXTENDED RELEASE;ORAL; 15MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
OXYMORPHONE HYDROCHLORIDE OXYMORPHONE HYDROCHLORIDE 15MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 079046 ACTAVIS ELIZABETH
OXYMORPHONE HYDROCHLORIDE OXYMORPHONE HYDROCHLORIDE 15MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 200822 HIKMA
OXYMORPHONE HYDROCHLORIDE OXYMORPHONE HYDROCHLORIDE 15MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 079087 IMPAX LABS
OXYMORPHONE HYDROCHLORIDE OXYMORPHONE HYDROCHLORIDE 15MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 202946 SPECGX LLC

TABLET, EXTENDED RELEASE;ORAL; 20MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
OXYMORPHONE HYDROCHLORIDE OXYMORPHONE HYDROCHLORIDE 20MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 079046 ACTAVIS ELIZABETH
OXYMORPHONE HYDROCHLORIDE OXYMORPHONE HYDROCHLORIDE 20MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 200822 HIKMA
OXYMORPHONE HYDROCHLORIDE OXYMORPHONE HYDROCHLORIDE 20MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 079087 IMPAX LABS
OXYMORPHONE HYDROCHLORIDE OXYMORPHONE HYDROCHLORIDE 20MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 202946 SPECGX LLC

TABLET, EXTENDED RELEASE;ORAL; 30MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
OXYMORPHONE HYDROCHLORIDE OXYMORPHONE HYDROCHLORIDE 30MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 079046 ACTAVIS ELIZABETH
OXYMORPHONE HYDROCHLORIDE OXYMORPHONE HYDROCHLORIDE 30MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 200822 HIKMA
OXYMORPHONE HYDROCHLORIDE OXYMORPHONE HYDROCHLORIDE 30MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 079087 IMPAX LABS
OXYMORPHONE HYDROCHLORIDE OXYMORPHONE HYDROCHLORIDE 30MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 202946 SPECGX LLC

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